EN ISO TS 19256-2017 en Health informatics - Requirements for medicinal product dictionary systems for health care.pdf

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1、Health informatics Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016)PD CEN ISO/TS 19256:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordT h i s P u b l i s h e d D o c u m e n t i s t h e U K i m p l e m e

2、n t a t i o n o f C E N I S O / T S1 9 2 5 6 : 2 0 1 7 . It is identical to ISO/TS 19256:2016.The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics.A list of organizations represented on this committee can be obtained onrequest to its secretary.This p

3、ublication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2017.Published by BSI Standards Limited 2017ISBN 978 0 580 84766 0ICS 35.240.80Compliance with a British Standard cannot confer immun

4、ity fromlegal obligations.This Published Document was published under the authority of theStandards Policy and Strategy Committee on 31 March 2017.Amendments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD CEN ISO/TS 19256:2017TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE

5、TECHNISCHE SPEZIFIKATION CEN ISO/TS 19256 March 2017 ICS 35.240.80 English Version Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016) Informatique de sant - Exigences pour les systmes de dictionnaires de produits mdicaux pour les soins de s

6、ant (ISO/TS 19256:2016) Medizinische Informatik - Anforderungen an Arzneimittelverzeichnisse im Gesundheitsbereich (ISO/TS 19256:2016) This Technical Specification (CEN/TS) was approved by CEN on 23 January 2017 for provisional application. The period of validity of this CEN/TS is limited initially

7、to three years. After two years the members of CEN will be requested to submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard. CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN

8、/TS available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached. CEN members are the national standards bodies of

9、Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia,

10、Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved world

11、wide for CEN national Members. Ref. No. CEN ISO/TS 19256:2017 EPD CEN ISO/TS 19256:2017CEN ISO/TS 19256:2017 (E) 2 Contents Page European foreword . 3 PD CEN ISO/TS 19256:2017CEN ISO/TS 19256:2017 (E) 3 European foreword The text of ISO/TS 19256:2016 has been prepared by Technical Committee ISO/TC 2

12、15 “Health informatics” of the International Organization for Standardization (ISO) and has been taken over as CEN ISO/TS 19256:2017 by Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held by NEN. Attention is drawn to the possibility that some of the elements of this

13、 document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to announce this Technical Speci

14、fication: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia,

15、Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO/TS 19256:2016 has been approved by CEN as CEN ISO/TS 19256:2017 without any modification. PD CEN ISO/TS 19256:2017ISO/TS 19256:2016(E)Foreword vIntroduction vi1 Scope . 12 Normative references 23

16、Terms and definitions . 24 Abbreviated terms 95 Boundary between MPD-systems and IDMP, ancillary information to build an MPD-system and local implementation. 95.1 Boundary between MPD-systems and IDMP 95.2 Boundary between MPD-systems and ancillary information to build an MPD-system . 95.3 Boundary

17、between MPD-systems and local implementation 95.4 Content of the MPD-systems in terms of product coverage 105.5 Definition of Medicinal Product Dictionary MPD-systems 105.6 Benefits of the Technical Specification 105.7 Target users for the Technical Specification . 106 Positioning of Medicinal Produ

18、ct Dictionary Systems for Healthcare .116.1 Base materials for MPD-systems 116.1.1 Relation with ISO IDMP standards 126.1.2 Relation with health/clinical/pharmacy information systems, decision support, EHR and dose instructions 136.1.3 Relation with EHR-S FM 146.2 Use cases for requirements for an M

19、PD-system .146.2.1 Prescribing use case .156.2.2 Dispensing use case 156.2.3 Administration use case . 156.2.4 Recording medication history use case .156.2.5 Reconciling medication list use case .156.2.6 Ordering and supply chain (logistics) use case 166.2.7 Analysis, statistics, and pharmacoepidemi

20、ology use case 166.2.8 Electronic data exchange of medicinal product information between healthcare systems and/or related systems, i.e. reporting use case 166.2.9 Reimbursement use case . 166.2.10 Clinical research use case 166.2.11 Tracking and tracing for patient and public safety use case .176.2

21、.12 Pharmacovigilance use case 176.2.13 Patient safety through linking personal data with the decision support system on medicinal products use case 186.2.14 Migration use case .187 The Functional Requirements for MPD-systems 187.1 Introduction . 187.2 Goal of an MPD system 197.3 Normative content 1

22、97.3.1 Content of regulated medicinal products 197.3.2 Prescription . 237.3.3 Dispensing 237.3.4 Administration 247.3.5 Recording and reconciliation . 247.3.6 Order and supply chain and logistics 257.3.7 Analysis, statistics, pharmacoepidemiology, and clinical research .257.3.8 Ensuring patient safe

23、ty through linking personal data with the decision support system on medicinal products .277.3.9 Interaction with reimbursement systems 27 ISO 2016 All rights reserved iiiContents PagePD CEN ISO/TS 19256:2017ISO/TS 19256:2016(E)7.3.10 Interaction of MPD-systems with pharmacovigilance systems 277.3.1

24、1 Data exchange and technical functions .287.4 Governance 297.5 Maintenance . 307.5.1 Regular maintenance processes of the MPD-system .307.5.2 Interaction with regulatory information .317.6 Localization . 32Annex A (informative) IDMP series in context, serving this Technical Specification33Bibliogra

25、phy .35iv ISO 2016 All rights reservedPD CEN ISO/TS 19256:2017ISO/TS 19256:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through

26、 ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborate

27、s closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval crit

28、eria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of

29、 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name

30、used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical

31、Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 215, Health informatics. ISO 2016 All rights reserved vPD CEN ISO/TS 19256:2017ISO/TS 19256:2016(E)IntroductionThis introduction contains the following topics:a) W

32、hat is a Medicinal Product Dictionary system?b) What are the use cases and who are the stakeholders?c) What are the benefits for the different stakeholders?d) What are the core functional requirements for an MPD-system for healthcare?The main target audience is the developers and service providers o

33、f MPD-systems, and those who contract such developers and service providers.The goal of MPD Systems is to offer various parties in healthcare a complete overview of available medicinal products in such a way the (elements of the) concepts and the descriptions and medicinal product identifiers can be

34、 used in a variety of other healthcare information systems. The principle for this Technical Specification is that the global unique IDs of IDMP (Identification of Medicinal Products) shall be maintained in any MPD-system.Medicinal products play an important role in healthcare. There are many (thous

35、ands of) medicinal products and each medicinal product has many characteristics (attributes), both defining and non-defining. The development and use of medicinal products is highly regulated; currently the way to define information about them is guided by the ISO IDMP standards. Furthermore, many h

36、ealthcare providers, institutions and enterprises are involved in the use of medicinal products. Each of these actors uses information systems in which information on medicinal products is stored and exchanged. These information systems need an MPD-system to accurately and consistently identify medi

37、cation concepts in the form(s) that fulfill their use cases.An MPD-system establishes a consistent representation of medication concepts (set of identifiers) at various levels of detail and with meaningful relationships between the concepts, in order to support parts of several processes in healthca

38、re in which medication plays a role. This Technical Specification describes a Medicinal Product Dictionary system in that way, that the concepts, identifiers and the relationships form a kind of structure that supports the use cases; together with the description of how this structure supports the u

39、se cases and what is needed for that. The MPD-system is further described from within an architecture in which it is connected to other parts of healthcare information systems.Cultural differences in the practice and delivery of care and national legislation require electronic MPD-systems that meet

40、specific local, regional or national needs. Each MPD-system is designed to support a particular set of use cases, which helps to determine the functional requirements which must be met by such systems. These functional requirements will then, in turn, determine the specific collection of medication

41、abstractions which must be identified, defined and related to each other within the MPD-system. Each medicinal product in the MPD-system is described in terms of a specific subset of all possible defining and non-defining information elements, which together enable it to support one or more specific

42、 use case(s). The concepts are formally defined in terms of their characteristics and relationships with other concepts according to the ISO IDMP Standards, in particular ISO 11615, ISO 11616 and ISO 11238. Relationships between each of these medicinal product entries give the MPD-system the potenti

43、al to support interoperability between use cases, processes, information systems, organizations and jurisdictions.The anticipated stakeholders of this Technical Specification include healthcare providers that have responsibilities in selecting appropriate MPD-systems, software vendors, governments,

44、pharmaceutical companies, wholesalers, payers, drugs regulatory authorities, and patients / patients organizations.In general, this Technical Specification supports the following business goals: It provides information to MPD-system developers, to help them design MPD-systems which are better able t

45、o meet the ISO IDMP standards and the needs of multiple use cases;vi ISO 2016 All rights reservedPD CEN ISO/TS 19256:2017ISO/TS 19256:2016(E) It facilitates accuracy and consistency of the use of concepts and terms according to the ISO IDMP standards in the MPD-systems; It increases the potential fo

46、r consistency between MPD-systems around the world; It reduces redundancy of data collection and governance; It provides the foundations for future international standards, which help to enable interoperability between medication use cases, information systems, and jurisdictions involved in cross-bo

47、rder healthcare; It might reduce the cost of developing and maintaining medicinal product dictionaries systems.The Technical Specification is partly based on the following terminologies / databases:- The Australian Medicinal Terminology (AMT);- NHS dictionary of medicines and devices (DM+D);- Singap

48、ore Drug Database;- SNOMED CT;- Dutch G-Standaard from Z-Index (and Pharmabase from Healthbase) (NEN 7507);- ISO/TR 22790, Health informatics Functional characteristics of prescriber support systems. ISO 2016 All rights reserved viiPD CEN ISO/TS 19256:2017Health informatics Requirements for medicina

49、l product dictionary systems for health care1 ScopeThis Technical Specification defines the required characteristics for any MPD-system to support use cases in healthcare.These characteristics include the medication concepts, identifiers and relationships to form a kind of structure that supports the use cases.In order to support the use cases, an MPD-system needs to: be comprehensive and exhaustive as far as possible unless all medicinal products that are in scope are included, other systems cannot fully rely on the MPD-system to